Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-01-03 @ 10:16 AM
Study NCT ID:
NCT03358069
Status:
COMPLETED
Last Update Posted:
2017-11-30
First Post:
2017-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Emergence Time Relate With Emergence Agitation in Pediatric Patients?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071257', 'term': 'Emergence Delirium'}], 'ancestors': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}, 'targetDuration': '7 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-29', 'studyFirstSubmitDate': '2017-11-02', 'studyFirstSubmitQcDate': '2017-11-29', 'lastUpdatePostDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'emergence agitation', 'timeFrame': 'evaluate patient within the first 5 minutes after patient arrive PACU', 'description': 'Pediatric Anesthesia Emergence delirium scale (PAED) PAED \\> 10 defined as EA positive'}], 'secondaryOutcomes': [{'measure': 'Post operative behavioral changes', 'timeFrame': 'up to 7 days postoperative period', 'description': 'PHBQ (post hospitalization behavioral questionnaires)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Emergence Agitation, Post Operative Behavioral Changes']}, 'descriptionModule': {'briefSummary': "Emergence agitation (EA) is one of the unpleasant symptoms after general anesthesia. The patient can be irritable, uncooperate, cry, moan and combative behaviors. Sometimes the patient may need to be thrashed to prevent physical harm. The mechanism of EA is still unknown. EA is usually self limiting within 45 to 60 minutes after wake up from anesthesia. The incidence of EA is much higher in pediatric group when compared with adult. In some centre the incidence of EA can be up to 67 % depends on anesthesia technique, race, and child's temperament. Kain et al, reported that the patient who had marked EA tended to have post operative maladaptive behaviors. These maladaptive behaviors such as insomnia, eating disturbance, aggressive behavior and even developmental regression can be happen until one year after anesthesia.\n\nFrom the previous study, reported that fast emergence was associated with a high incidence of agitation.\n\nThis prospective observation study is conducted to determine that emergence time has any effect on EA or not. The authors use process electroencephalogram (entropy) to monitor emergence time which defined as the time which state entropy level over sixty to eighty. Meanwhile, we will evaluate the emergence time by the conventional method which used the time from ceasing anesthesia to the time of eye opening by normal voice stimuli.\n\nThe primary outcome of this study is the correlation between emergence time (both from Process EEG and clinical presentation) and incidence of emergence agitation. Two secondary outcomes will be measured. Firstly, the correlation between emergence time and postoperative behavioral changes. Secondly, the relationship between entropy monitoring and clinical symptoms."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric patient aged between 3-12 years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPediatric patient aged between 3-12 years, ASA physical status I-II who is scheduled for inpatient elective surgery\n\nExclusion Criteria:\n\nemergency surgery, neurosurgery, antiepileptic medication taken and having ICU admission planning.'}, 'identificationModule': {'nctId': 'NCT03358069', 'briefTitle': 'Does Emergence Time Relate With Emergence Agitation in Pediatric Patients?', 'organization': {'class': 'OTHER', 'fullName': 'Prince of Songkla University'}, 'officialTitle': 'Does Emergence Time Relate With Emergence Agitation in Pediatric Patients?', 'orgStudyIdInfo': {'id': 'PSU EA 3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'deep anesthetic state', 'description': 'technique of Anesthesia at the time of airway device removal', 'interventionNames': ['Diagnostic Test: Emergence agitation scale']}, {'label': 'awake', 'description': 'technique of Anesthesia at the time of airway device removal', 'interventionNames': ['Diagnostic Test: Emergence agitation scale']}, {'label': 'emergence time (clinical): min', 'description': 'The duration from the time of anesthestic medications stop and the time that patient spontaneously open their eyes', 'interventionNames': ['Diagnostic Test: Emergence agitation scale']}, {'label': 'Emergence time (entropy): min', 'description': 'time from Entropy value above 60 to 90', 'interventionNames': ['Diagnostic Test: Emergence agitation scale']}], 'interventions': [{'name': 'Emergence agitation scale', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Post operative behavioral changes'], 'description': 'Emergence agitation scale: PAED scale \\> 10 defined as positive for Emergence agitation (EA) Post hospitalize behavioral questionnaire (PHBQ) positive Post operative behavioral changes defines as 10 % change from sum score of PHBQ', 'armGroupLabels': ['Emergence time (entropy): min', 'awake', 'deep anesthetic state', 'emergence time (clinical): min']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90110', 'city': 'Hat Yai', 'state': 'Changwat Songkhla', 'country': 'Thailand', 'facility': 'Prince of Songkla University', 'geoPoint': {'lat': 7.00836, 'lon': 100.47668}}], 'overallOfficials': [{'name': 'Ngamjit Pattaravit, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Prince of Songkla University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prince of Songkla University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asst. Prof.', 'investigatorFullName': 'Ngamjit Pattaravit', 'investigatorAffiliation': 'Prince of Songkla University'}}}}